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510(k) Data Aggregation
K Number
K080833Device Name
LOVE GUARD MALE LATEX CONDOM
Manufacturer
Date Cleared
2008-08-07
(135 days)
Product Code
Regulation Number
884.5300Why did this record match?
Applicant Name (Manufacturer) :
TIANJIN HUMAN-CARE LATEX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This latex condom has the same intended use as the predicate condom. This condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases. If used properly, this condom will help to reduce the risk of transmission of HIV infection and many other sexually transmitted diseases including syphilis, chlamydia infections, genital herpes, genital warts, gonorrhea, hepatitis B. etc.
Device Description
This condom is made of a natural latex sheath, which completely covers the penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip. Its nominal length is 185 - 190 mm, nominal width 50.5 -51.5 mm, and nominal thickness 0.06 - 0.08 mm. It is offered in natural latex color and lubricated with polydimethylsiloxane (silicone) with cornstarch as the dressing material. This condom is designed to conform to established American and international voluntary standards including ASTM D3492 and ISO 4074.
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